Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study.

BACKGROUND: Topical calcineurin inhibitors are used off label in the treatment of vitiligo, and there is a lack of placebo-controlled, blinded studies to support their use. OBJECTIVE: This study aimed to compare the efficacy of tacrolimus 0.1% ointment with that of the vehicle for repigmentation in adult patients with facial vitiligo. DESIGN: This study was a 24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension. POPULATION: Participants included were adult patients with recent facial vitiligo target lesions (<2 years) without changes in pigmentation or size over the previous 3 months. INTERVENTION: Patients received either tacrolimus 0.1% ointment or vehicle twice daily. MAIN OUTCOMES AND MEASURES: The primary outcome was a therapeutic success, defined as a change ≥75% in the repigmentation of the target lesion between baseline and week 24, measured by ImageJ software. Secondary outcome measures were a variation of the physicians' global assessment scores and patients' satisfaction scores, safety data, and the rate of relapse at week 48. RESULTS: A total of 42 patients were included. Therapeutic success was achieved in 65% of tacrolimus-treated patients versus 0% of vehicle-treated patients at week 24 (P < 0.0001). Only 40% of relapse was observed at 48 weeks. CONCLUSIONS AND RELEVANCE: Twice-daily tacrolimus 0.1% ointment showed superior efficacy to that of the vehicle through the 24 weeks of intervention and 24 weeks of follow-up in adult patients with facial vitiligo. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov (identifier: NCT02466997).